US20240197525A1 - Grasping structure for membrane removal - Google Patents
Grasping structure for membrane removal Download PDFInfo
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- US20240197525A1 US20240197525A1 US18/530,564 US202318530564A US2024197525A1 US 20240197525 A1 US20240197525 A1 US 20240197525A1 US 202318530564 A US202318530564 A US 202318530564A US 2024197525 A1 US2024197525 A1 US 2024197525A1
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- Prior art keywords
- arm
- outer tube
- polymer arm
- inner rod
- polymer
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- 239000012528 membrane Substances 0.000 title claims abstract description 34
- 229920000642 polymer Polymers 0.000 claims abstract description 34
- 230000002207 retinal effect Effects 0.000 claims abstract description 4
- 239000000463 material Substances 0.000 claims description 21
- 210000001525 retina Anatomy 0.000 claims description 21
- 238000000034 method Methods 0.000 claims description 7
- 229920002725 thermoplastic elastomer Polymers 0.000 claims description 6
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 5
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 claims description 5
- 229910000831 Steel Inorganic materials 0.000 claims description 2
- 239000010959 steel Substances 0.000 claims description 2
- 229920005570 flexible polymer Polymers 0.000 description 68
- 208000001351 Epiretinal Membrane Diseases 0.000 description 12
- 208000031471 Macular fibrosis Diseases 0.000 description 11
- 229910000639 Spring steel Inorganic materials 0.000 description 3
- 230000006835 compression Effects 0.000 description 3
- 238000007906 compression Methods 0.000 description 3
- 229910001220 stainless steel Inorganic materials 0.000 description 3
- 239000010935 stainless steel Substances 0.000 description 3
- 229920001296 polysiloxane Polymers 0.000 description 2
- 210000001747 pupil Anatomy 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 206010058202 Cystoid macular oedema Diseases 0.000 description 1
- 206010012688 Diabetic retinal oedema Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 208000001344 Macular Edema Diseases 0.000 description 1
- 208000002367 Retinal Perforations Diseases 0.000 description 1
- 206010057430 Retinal injury Diseases 0.000 description 1
- 208000035307 Vitreous adhesions Diseases 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 201000010206 cystoid macular edema Diseases 0.000 description 1
- 201000011190 diabetic macular edema Diseases 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000013013 elastic material Substances 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 208000029233 macular holes Diseases 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000008458 response to injury Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 208000000318 vitreous detachment Diseases 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/30—Surgical pincettes without pivotal connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/30—Surgical pincettes without pivotal connections
- A61B2017/305—Tweezer like handles with tubular extensions, inner slidable actuating members and distal tools, e.g. microsurgical instruments
Definitions
- the internal limiting membrane is a thin transparent membrane positioned between the vitreous and the retina of the eye.
- the ILM plays a role during the formation of the eye but is not required for the proper function of an adult eye.
- the ILM may pull at the retina and cause conditions such as macular holes, macular pucker, vitreo-macular traction syndrome, diabetic macular edema, and cystoid macular edema secondary to inflammation or venous occlusive diseases and other conditions.
- An epiretinal membrane is a membrane that may form over the retina in response to damage to the retina, such as due to posterior vitreous detachment.
- the ILM or ERM may need to be peeled away from the retina to prevent damage to the retina. Peeling of the ILM or ERM may also be required in preparation for surgical procedures performed on the retina.
- a surgical instrument is inserted through a cannula within the patient's eye globe. Forceps or a specialized scraper are extended from the instrument and used to raise a flap in the ILM or ERM. The flap is then grasped by the forceps and the ILM or ERM is peeled away from the retina using a circular motion. Excess force on the forceps may, however, result in piercing of the retina.
- the present disclosure relates generally to a membrane peeling tool including a grasping structure having flexible polymer arms with angled end surfaces.
- An ophthalmic surgical instrument for peeling a retinal membrane includes a handle and an actuator mounted on the handle.
- An outer tube has a proximal end mounted to the handle and defining a longitudinal direction.
- An inner rod extends within the outer tube.
- a grasping structure is secured to a distal end of the inner rod.
- the grasping structure includes a first polymer arm and a second polymer arm secured to the inner rod and biased outwardly from one another along a transverse direction perpendicular to the longitudinal direction.
- Each of the first polymer arm and the second polymer arms has a distal end that is at an angle between 0 and 90 degrees (e.g., between 10 and 60 degrees) relative to a vertical direction that is perpendicular to the longitudinal direction and the transverse direction.
- the actuator is configured to control relative position of the inner rod and the outer tube in order to extend the grasping structure out of the outer tube and withdraw the grasping structure within the outer tube.
- FIG. 1 is an isometric view of a surgical instrument having a grasping structure including flexible polymer arms, in accordance with certain embodiments.
- FIG. 2 A is an isometric view of an arm of a flexible polymer arm, in accordance with certain embodiments.
- FIG. 2 B is an isometric view of an alternative shape for a flexible polymer arm, in accordance with certain embodiments.
- FIG. 2 C is an isometric view illustrating texturing on an inner surface of a flexible polymer arm, in accordance with certain embodiments.
- FIG. 2 D is an isometric view illustrating a flexible polymer arm molded over an extension of an inner tube, in accordance with certain embodiments
- FIG. 3 is an isometric view of an alternative embodiment for actuators for controlling the grasping structure, in accordance with certain embodiments.
- FIG. 4 A is an isometric view showing flexible polymer arms in an open configuration, in accordance with certain embodiments.
- FIG. 4 B is an isometric view showing the flexible polymer arms in a closed configuration, in accordance with certain embodiments
- FIGS. 5 A to 5 C are side cross-sectional views showing the peeling of an ILM using the grasping structure, in accordance with certain embodiments.
- FIG. 6 is an isometric view showing an ILM being peeled using the grasping structure, in accordance with certain embodiments.
- a surgical instrument including a grasping structure with flexible polymer arms for peeling a membrane from a patient's retina.
- a distal end of a component refers to the end that is closer to a patient's body while the proximal end of the component refers to the end that is facing away from the patient's body or in proximity to, for example, the handle of the surgical instrument.
- FIG. 1 illustrates a surgical instrument 100 , in accordance with certain embodiments of the present disclosure.
- the surgical instrument includes a handle 102 that is sized and contoured to be grasped by a hand of a surgeon performing an ophthalmic surgical procedure, including the peeling of a membrane from a retina of a patient's eye, such as an internal limiting membrane (ILM) or epiretinal membrane (ERM).
- a grasping structure 104 is extendable from a distal end of an outer tube 106 connected to the handle 102 , while a proximal end of the outer tube 106 is connected to the handle 102 .
- the handle 102 may have one or more manual control structures mounted thereto.
- the manual control structures include a deformable basket 110 .
- the manual control structure shown is exemplary only, and other manual control structures may also be used (see, for example, FIG. 3 ).
- the grasping structure 104 is embodied as forceps comprising a first flexible polymer arm 112 and a second flexible polymer arm 114 .
- the first flexible polymer arm 112 and second flexible polymer arm 114 are connected to an inner rod 116 that is slidably positioned within the outer tube 106 .
- the inner rod 116 may be implemented as a solid rod, or alternatively, as a hollow tube.
- the first flexible polymer arm 112 has an end 112 a fastened to the inner rod 116 either directly or by way of an intermediate arm 116 a .
- the second flexible polymer arm 114 has an end 114 a fastened to the inner rod 116 either directly or by way of an intermediate arm 116 b .
- the outer tube 106 , inner rod 116 , and arms 116 a , 116 b may be made of nitinol, stainless steel, spring steel, rigid polymer, or other material.
- the flexible polymer arms may be made of a softer material than the tubes (e.g., silicone).
- the arms 116 a , 116 b may be secured to or monolithically formed with the inner rod 116 .
- the deformable basket 110 of the handle 102 is coupled to the outer tube 106 .
- the outer tube 106 may be extended over the first flexible polymer arm 112 and second flexible polymer arm 114 of the grasping structure 104 , such as while the outer tube 106 is inserted into or withdrawn from a cannula (e.g., referred to as a trocar cannula) inserted in the patient's eye.
- a cannula e.g., referred to as a trocar cannula
- the outer tube 106 may then be withdrawn or retracted, thereby extending the inner rod 116 and grasping structure 104 relative to the outer tube 106 .
- the outer tube 106 may be extended over the inner rod 116 , thereby retracting the inner rod 116 and grasping structure 104 relative to the outer tube 106 .
- the deformable basket 110 is coupled to the inner rod 116 and the outer tube 106 is fixed relative to the handle 102 . Accordingly, extension of the inner rod 116 and grasping structure 104 may be accomplished by compressing the deformable basket 110 , whereas releasing of compression of the deformable basket 110 retracts the inner rod 116 and grasping structure 104 into the outer tube 106 .
- first flexible polymer arm 112 and second flexible polymer arm 114 When extended from the outer tube 106 , the first flexible polymer arm 112 and second flexible polymer arm 114 are biased outwardly from one another.
- the outer tube 106 may be extended relative to the inner rod 116 in order to press the first flexible polymer arm 112 and second flexible polymer arm 114 together and grasp a membrane, e.g., an ILM or ERM.
- the first flexible polymer arm 112 and second flexible polymer arm 114 may be made of a highly flexible material, such as thermoplastic elastomer, silicone, or other elastic material.
- the thermoplastic elastomer may be selected to provide sufficient rigidity to grasp the membrane while being sufficiently soft to reduce risk of puncturing the retina.
- the thermoplastic elastomer may have a hardness of between about 10 and about 90 Shore A, such as between about 20 and about 80 Shore A, such as between about 30 and about 60 Shore A.
- the softness of the flexible material forming the flexible polymer arms 112 , 114 may be selected in combination with a rigidity of the arms 116 a , 116 b around which the flexible polymer arms 112 , 114 are molded—with increasing softness, the arms 116 a , 116 b may be made correspondingly more rigid to enable gripping of the membrane.
- the arms 116 a , 116 b when used, may likewise be made of a highly flexible material, such as steel, stainless steel, spring steel, nitinol, or a polymer.
- the high flexibility enables the first flexible polymer arm 112 and second flexible polymer arm 114 , and the arms 116 a , 116 b when used, to elastically deform in order to fit within the outer tube 106 and, when extended from the outer tube 106 , expand to a size that is much wider than an outer diameter of the outer tube 106 .
- the first flexible polymer arm 112 and second flexible polymer arm 114 , and the arms 116 a , 116 b when used, may expand to at least two times, four times, eight times, or sixteen times the outer dimeter of the outer tube 106 in certain embodiments.
- the outer tube 106 defines a longitudinal direction 120 a parallel to and collinear with an axis of symmetry of the outer tube 106 .
- the axes of symmetry of the inner rod 116 is substantially (e.g., within 0.5 mm (millimeters)) collinear with the longitudinal direction 120 a and substantially (e.g., within 5 degrees of) parallel to the longitudinal direction 120 a .
- a transverse direction 120 b may also be defined as perpendicular to the longitudinal direction 120 a .
- a vertical direction 120 c may be defined as perpendicular to the longitudinal direction 120 a and the transverse direction 120 b.
- the flexible polymer arms 112 , 114 may have a generally quadrilateral cross section including surfaces 112 b , 114 b and surfaces 112 c , 114 c that are substantially (e.g., within 5 degrees) parallel to the longitudinal direction 120 a , and the transverse direction 120 b (“the longitudinal-transverse plane”).
- An end surface 112 d , 114 d extends between the surface 112 b , 114 b and the surface 112 c , 114 c of each of the flexible polymer arms 112 , 114 .
- the surface 112 d , 114 d is substantially (e.g., within 5 degrees of) parallel to the vertical direction 120 c .
- the surface 112 d , 114 d is at an angle with respect to the vertical direction 120 c , such as an angle between 10° and 60°, between 20° and 50°, between 30° and 45°, or between 0° and 90°.
- the flexible polymer arms 112 , 114 may also include a grasping platform such as in the 705.43, 705.44, or 705.45 ILM Forceps from ALCON or the MAXGRIP 705.13 forceps from ALCON.
- An inner surface 112 f , 114 f and an outer surface 112 g , 114 g extend between the surface 112 b , 114 b and the surface 112 c , 114 c of each flexible polymer arm 112 , 114 .
- the inner surface 112 f , 114 f and/or the outer surface 112 g , 114 g may be curved in the longitudinal transverse plane and parallel to the vertical direction 120 c .
- the inner surfaces 112 f , 114 f are generally oriented facing one another and offset from one another in the transverse direction 120 b when the grasping structure 104 is extended from the outer tube 106 .
- the length of the flexible polymer arms 112 , 114 between the ends 112 a , 114 a and the end surfaces 112 d , 114 d and the flexibility of the material used to form the flexible polymer arms 112 , 114 may be selected to enable the flexible polymer arms 112 , 114 to deform when placed in contact with the retina or the patient's eye, thereby reducing the risk of puncturing the retina while still providing sufficient rigidity to grasp the membrane.
- the flexibility of the flexible polymer arms 112 , 114 further enables the flexible polymer arms to flex, twist, or otherwise deform to enable the end surfaces 112 d , 114 d to rest flat on the membrane.
- the angle of the end surface 112 d , 114 d in the embodiment of FIG. 2 B may be selected to facilitate placement of the end surface 112 d , 114 d flat against the retina.
- the outer tube 106 is inserted through a trocar cannula that is offset from the pupil whereas the membrane is located directly behind the pupil, requiring the outer tube 106 to be angled with respect to the membrane at a point of contact between the grasping structure 104 and the membrane.
- the angled orientation of the end surface 112 d , 114 d may therefore compensate for the angle of the outer tube 106 and promote flat placement of the end surface 112 d , 114 d on the membrane.
- FIGS. 2 A and 2 B are exemplary only. Other shapes, including shapes with rounded rather than quadrilateral shapes, may be used. For example, a round, oval, elliptical, or other cross sectional shape may be used with the distal end surface of such a shape being flat or angled as described above with respect to the end surface 112 d , 114 d.
- the inner surfaces 112 f , 114 f of one or both of the first flexible polymer arm 112 and second flexible polymer arm 114 may have texturing formed thereon to facilitate gripping of the membrane.
- the inner surfaces 112 f , 114 f may have grooves 122 formed thereon.
- the grooves 122 are oriented parallel to the vertical direction 120 c , but grooves having other orientations may additionally or alternatively be used. In this manner, the grooves 122 enhance the ability of the inner surfaces 112 f , 114 f to grasp a flap raised between the end surfaces 112 d , 114 d .
- texturing may include, but is not limited to, bumps, raised ridges, knurling, or other type of texturing.
- the flexible polymer arm 112 , 114 may be formed over an extension 150 of the material of the inner rod 116 , such as an arm 116 a , 116 b .
- adhesive is added to the outer surface of the extension 150 before the material of the flexible polymer arm 112 , 114 is molded over the extension 150 .
- the material of the extension 150 may be the same material as the inner rod 116 , including nitinol, stainless steel, spring steel, rigid polymer, or other material.
- the extension 150 may be a rectangular prism or a cylinder. In certain embodiments, the extension may have texturing to facilitate bonding with the flexible polymer arm 112 , 114 .
- the extension 150 extends from the distal end of the inner rod 116 , such as an arm 116 a , 116 b .
- the material of the flexible polymer arm 112 , 114 extends over the extension 150 so that the distal end 151 of the extension 150 is within the material of the flexible polymer arm 112 , 114 and does not extend through the flexible polymer arm 112 , 114 . Stated differently, a portion of the flexible polymer arm 112 , 114 extends beyond the extension 150 in the longitudinal direction 120 a .
- the extension 150 have the same flexibility as the flexible polymer arm 112 , 114 , or may be more or less flexible.
- various actuation mechanisms may be used to control translation of the outer tube 106 and the inner rod 116 .
- the deformable basket 110 may be replaced with a slider 200 that is slidably mounted to the handle 102 .
- the slider 200 slides within a slot 202 defined by the handle 102 .
- the slider 200 is coupled to the outer tube 106 and the inner rod 116 is coupled to the handle 102 , so that the inner tube is fixed relative to the handle 102 , and movement of the slider 200 moves the outer tube 106 over the inner rod 116 .
- the slider 200 is coupled to the inner rod 116 and the outer tube 106 is coupled to the handle 102 , so that the outer tube 106 is fixed relative to the handle 102 , and movement of the slider 200 moves the inner rod 116 within the outer tube 106 .
- the first flexible polymer arm 112 and the second flexible polymer arm 114 may be positioned in the illustrated “open” configuration with a gap 400 between the end surface 112 d and the end surface 114 d that is many times greater than the thickness of the membrane (for example, at least 10, 100, or 1000 times the thickness of the membrane).
- the outer tube 106 may be extended partially or completely over the first flexible polymer arm 112 and the second flexible polymer arm 114 , or over the arms 116 a , 116 b , at any point during use of the surgical instrument 100 to form a “closed” position.
- the stiffness of the first flexible polymer arm 112 and the second flexible polymer arm 114 may be increased by extending the outer tube 106 and reducing the portions of the first flexible polymer arm 112 and the second flexible polymer arm 114 that are positioned outwardly from the outer tube 106 .
- the outer tube 106 may be withdrawn to the point where more, potentially the entirety, of the first flexible polymer arm 112 and the second flexible polymer arm 114 are exposed.
- the amount of the arms 116 a , 116 b extending from the outer tube 106 may be controlled in order to control stiffness of the combined flexible polymer arms 112 , 114 and arms 116 a , 116 b.
- the outer tube 106 may be extended until either (a) the first flexible polymer arm 112 and the second flexible polymer arm 114 are located completely within the outer tube 106 , or (b) the parts the first flexible polymer arm 112 and the second flexible polymer arm 114 extending outwardly form the outer tube 106 are small enough to fit through the cannula (e.g., equal to or smaller than the outer diameter of the outer tube 106 ).
- the forceps (flexible polymer arms 112 and 114 thereof) are slightly curved inward and the end surfaces 112 d , 114 d are angled such that the end surfaces 112 d , 114 d meet each other when the forceps are closed.
- Other embodiments may include different shapes of forceps and/or different angles for end surfaces 112 d , 114 d .
- the flexible polymer arms 112 and 114 may not curve inward, the flexible polymer arms 112 and 114 may curve outward, or the flexible polymer arms 112 and 114 may be straight or substantially straight.
- FIG. 5 A during use, lower surfaces of the end surfaces 112 d , 114 d are pressed downward against the membrane 500 (e.g., ILM or ERM) positioned over the retina 502 .
- a flap 504 may be raised by drawing the end surfaces 112 d , 114 d towards each other across the membrane 500 in order to grasp the flap 504 firmly.
- the surgeon may then lift the surgical instrument 100 away from the retina 502 in order to tear the membrane 500 .
- the surgeon may move the grasping structure 104 in a circular motion to peel a portion of the membrane 500 away from the retina 502 .
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Abstract
An ophthalmic surgical instrument for peeling a retinal membrane includes a handle and an actuator mounted on the handle. An outer tube is mounted to the handle and an inner rod extends within the outer tube. A grasping structure is secured to a distal end of the inner rod having first and second polymer arms secured to the inner rod. Each of the first polymer arm and the second polymer arms has a distal end that is angled to conform to the retinal membrane. The actuator is configured to control relative position of the inner rod and the outer tube in order to extend the grasping structure out of the outer tube and withdraw the grasping structure within the outer tube.
Description
- The internal limiting membrane (ILM) is a thin transparent membrane positioned between the vitreous and the retina of the eye. The ILM plays a role during the formation of the eye but is not required for the proper function of an adult eye. The ILM may pull at the retina and cause conditions such as macular holes, macular pucker, vitreo-macular traction syndrome, diabetic macular edema, and cystoid macular edema secondary to inflammation or venous occlusive diseases and other conditions. An epiretinal membrane (ERM) is a membrane that may form over the retina in response to damage to the retina, such as due to posterior vitreous detachment.
- The ILM or ERM may need to be peeled away from the retina to prevent damage to the retina. Peeling of the ILM or ERM may also be required in preparation for surgical procedures performed on the retina. To peel the ILM or ERM, a surgical instrument is inserted through a cannula within the patient's eye globe. Forceps or a specialized scraper are extended from the instrument and used to raise a flap in the ILM or ERM. The flap is then grasped by the forceps and the ILM or ERM is peeled away from the retina using a circular motion. Excess force on the forceps may, however, result in piercing of the retina.
- Accordingly, it would be an advancement in the art to reduce the risk of retinal damage resulting from membrane peeling.
- The present disclosure relates generally to a membrane peeling tool including a grasping structure having flexible polymer arms with angled end surfaces.
- An ophthalmic surgical instrument for peeling a retinal membrane includes a handle and an actuator mounted on the handle. An outer tube has a proximal end mounted to the handle and defining a longitudinal direction. An inner rod extends within the outer tube. A grasping structure is secured to a distal end of the inner rod. The grasping structure includes a first polymer arm and a second polymer arm secured to the inner rod and biased outwardly from one another along a transverse direction perpendicular to the longitudinal direction. Each of the first polymer arm and the second polymer arms has a distal end that is at an angle between 0 and 90 degrees (e.g., between 10 and 60 degrees) relative to a vertical direction that is perpendicular to the longitudinal direction and the transverse direction. The actuator is configured to control relative position of the inner rod and the outer tube in order to extend the grasping structure out of the outer tube and withdraw the grasping structure within the outer tube.
- The following description and the related drawings set forth in detail certain illustrative features of one or more embodiments.
- The appended figures depict certain aspects of the one or more embodiments and are therefore not to be considered limiting of the scope of this disclosure.
-
FIG. 1 is an isometric view of a surgical instrument having a grasping structure including flexible polymer arms, in accordance with certain embodiments. -
FIG. 2A is an isometric view of an arm of a flexible polymer arm, in accordance with certain embodiments. -
FIG. 2B is an isometric view of an alternative shape for a flexible polymer arm, in accordance with certain embodiments. -
FIG. 2C is an isometric view illustrating texturing on an inner surface of a flexible polymer arm, in accordance with certain embodiments. -
FIG. 2D is an isometric view illustrating a flexible polymer arm molded over an extension of an inner tube, in accordance with certain embodiments -
FIG. 3 is an isometric view of an alternative embodiment for actuators for controlling the grasping structure, in accordance with certain embodiments. -
FIG. 4A is an isometric view showing flexible polymer arms in an open configuration, in accordance with certain embodiments. -
FIG. 4B is an isometric view showing the flexible polymer arms in a closed configuration, in accordance with certain embodiments -
FIGS. 5A to 5C are side cross-sectional views showing the peeling of an ILM using the grasping structure, in accordance with certain embodiments. -
FIG. 6 is an isometric view showing an ILM being peeled using the grasping structure, in accordance with certain embodiments. - To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the drawings. It is contemplated that elements and features of one embodiment may be beneficially incorporated in other embodiments without further recitation.
- Aspects of the present disclosure provide a surgical instrument including a grasping structure with flexible polymer arms for peeling a membrane from a patient's retina. Note that, herein, a distal end of a component refers to the end that is closer to a patient's body while the proximal end of the component refers to the end that is facing away from the patient's body or in proximity to, for example, the handle of the surgical instrument.
-
FIG. 1 illustrates asurgical instrument 100, in accordance with certain embodiments of the present disclosure. The surgical instrument includes ahandle 102 that is sized and contoured to be grasped by a hand of a surgeon performing an ophthalmic surgical procedure, including the peeling of a membrane from a retina of a patient's eye, such as an internal limiting membrane (ILM) or epiretinal membrane (ERM). Agrasping structure 104 is extendable from a distal end of anouter tube 106 connected to thehandle 102, while a proximal end of theouter tube 106 is connected to thehandle 102. Thehandle 102 may have one or more manual control structures mounted thereto. In the embodiment ofFIG. 1 , the manual control structures include adeformable basket 110. The manual control structure shown is exemplary only, and other manual control structures may also be used (see, for example,FIG. 3 ). - In
FIG. 1 , thegrasping structure 104 is embodied as forceps comprising a firstflexible polymer arm 112 and a secondflexible polymer arm 114. The firstflexible polymer arm 112 and secondflexible polymer arm 114 are connected to aninner rod 116 that is slidably positioned within theouter tube 106. Theinner rod 116 may be implemented as a solid rod, or alternatively, as a hollow tube. - In the illustrated embodiments, the first
flexible polymer arm 112 has anend 112 a fastened to theinner rod 116 either directly or by way of anintermediate arm 116 a. The secondflexible polymer arm 114 has anend 114 a fastened to theinner rod 116 either directly or by way of anintermediate arm 116 b. Theouter tube 106,inner rod 116, andarms arms inner rod 116. - In some embodiments, the
deformable basket 110 of thehandle 102 is coupled to theouter tube 106. In use, theouter tube 106 may be extended over the firstflexible polymer arm 112 and secondflexible polymer arm 114 of thegrasping structure 104, such as while theouter tube 106 is inserted into or withdrawn from a cannula (e.g., referred to as a trocar cannula) inserted in the patient's eye. Upon releasing compression of thedeformable basket 110, theouter tube 106 may then be withdrawn or retracted, thereby extending theinner rod 116 andgrasping structure 104 relative to theouter tube 106. Upon compression of thedeformable basket 110, theouter tube 106 may be extended over theinner rod 116, thereby retracting theinner rod 116 andgrasping structure 104 relative to theouter tube 106. In other embodiments, thedeformable basket 110 is coupled to theinner rod 116 and theouter tube 106 is fixed relative to thehandle 102. Accordingly, extension of theinner rod 116 and graspingstructure 104 may be accomplished by compressing thedeformable basket 110, whereas releasing of compression of thedeformable basket 110 retracts theinner rod 116 and graspingstructure 104 into theouter tube 106. - When extended from the
outer tube 106, the firstflexible polymer arm 112 and secondflexible polymer arm 114 are biased outwardly from one another. Theouter tube 106 may be extended relative to theinner rod 116 in order to press the firstflexible polymer arm 112 and secondflexible polymer arm 114 together and grasp a membrane, e.g., an ILM or ERM. - The first
flexible polymer arm 112 and secondflexible polymer arm 114 may be made of a highly flexible material, such as thermoplastic elastomer, silicone, or other elastic material. The thermoplastic elastomer may be selected to provide sufficient rigidity to grasp the membrane while being sufficiently soft to reduce risk of puncturing the retina. For example, the thermoplastic elastomer may have a hardness of between about 10 and about 90 Shore A, such as between about 20 and about 80 Shore A, such as between about 30 and about 60 Shore A. The softness of the flexible material forming theflexible polymer arms arms flexible polymer arms arms arms flexible polymer arm 112 and secondflexible polymer arm 114, and thearms outer tube 106 and, when extended from theouter tube 106, expand to a size that is much wider than an outer diameter of theouter tube 106. For example, the firstflexible polymer arm 112 and secondflexible polymer arm 114, and thearms outer tube 106 in certain embodiments. - The
outer tube 106 defines alongitudinal direction 120 a parallel to and collinear with an axis of symmetry of theouter tube 106. The axes of symmetry of theinner rod 116 is substantially (e.g., within 0.5 mm (millimeters)) collinear with thelongitudinal direction 120 a and substantially (e.g., within 5 degrees of) parallel to thelongitudinal direction 120 a. Atransverse direction 120 b may also be defined as perpendicular to thelongitudinal direction 120 a. Avertical direction 120 c may be defined as perpendicular to thelongitudinal direction 120 a and thetransverse direction 120 b. - Referring now to
FIGS. 2A and 2B , theflexible polymer arms section including surfaces longitudinal direction 120 a, and thetransverse direction 120 b (“the longitudinal-transverse plane”). Anend surface surface surface flexible polymer arms FIG. 2A , thesurface vertical direction 120 c. In the embodiment ofFIG. 2B , thesurface vertical direction 120 c, such as an angle between 10° and 60°, between 20° and 50°, between 30° and 45°, or between 0° and 90°. Theflexible polymer arms - An
inner surface outer surface surface surface flexible polymer arm inner surface outer surface vertical direction 120 c. Theinner surfaces transverse direction 120 b when the graspingstructure 104 is extended from theouter tube 106. - The length of the
flexible polymer arms ends flexible polymer arms flexible polymer arms flexible polymer arms - The angle of the
end surface FIG. 2B may be selected to facilitate placement of theend surface outer tube 106 is inserted through a trocar cannula that is offset from the pupil whereas the membrane is located directly behind the pupil, requiring theouter tube 106 to be angled with respect to the membrane at a point of contact between the graspingstructure 104 and the membrane. The angled orientation of theend surface outer tube 106 and promote flat placement of theend surface - The illustrated shapes in
FIGS. 2A and 2B are exemplary only. Other shapes, including shapes with rounded rather than quadrilateral shapes, may be used. For example, a round, oval, elliptical, or other cross sectional shape may be used with the distal end surface of such a shape being flat or angled as described above with respect to theend surface - Referring now to
FIG. 2C , theinner surfaces flexible polymer arm 112 and secondflexible polymer arm 114 may have texturing formed thereon to facilitate gripping of the membrane. For example, theinner surfaces grooves 122 formed thereon. In the illustrated embodiment, thegrooves 122 are oriented parallel to thevertical direction 120 c, but grooves having other orientations may additionally or alternatively be used. In this manner, thegrooves 122 enhance the ability of theinner surfaces - Referring to
FIG. 2D , theflexible polymer arm extension 150 of the material of theinner rod 116, such as anarm extension 150 before the material of theflexible polymer arm extension 150. The material of theextension 150 may be the same material as theinner rod 116, including nitinol, stainless steel, spring steel, rigid polymer, or other material. Theextension 150 may be a rectangular prism or a cylinder. In certain embodiments, the extension may have texturing to facilitate bonding with theflexible polymer arm extension 150 extends from the distal end of theinner rod 116, such as anarm flexible polymer arm extension 150 so that thedistal end 151 of theextension 150 is within the material of theflexible polymer arm flexible polymer arm flexible polymer arm extension 150 in thelongitudinal direction 120 a. Theextension 150 have the same flexibility as theflexible polymer arm - Referring to
FIG. 3 , various actuation mechanisms may be used to control translation of theouter tube 106 and theinner rod 116. In some embodiments, thedeformable basket 110 may be replaced with aslider 200 that is slidably mounted to thehandle 102. In the illustrated embodiment, theslider 200 slides within aslot 202 defined by thehandle 102. In certain embodiments, theslider 200 is coupled to theouter tube 106 and theinner rod 116 is coupled to thehandle 102, so that the inner tube is fixed relative to thehandle 102, and movement of theslider 200 moves theouter tube 106 over theinner rod 116. In certain embodiments, theslider 200 is coupled to theinner rod 116 and theouter tube 106 is coupled to thehandle 102, so that theouter tube 106 is fixed relative to thehandle 102, and movement of theslider 200 moves theinner rod 116 within theouter tube 106. - Referring now to
FIG. 4A , in preparation for raising a flap during a procedure, the firstflexible polymer arm 112 and the secondflexible polymer arm 114 may be positioned in the illustrated “open” configuration with agap 400 between theend surface 112 d and theend surface 114 d that is many times greater than the thickness of the membrane (for example, at least 10, 100, or 1000 times the thickness of the membrane). - Referring to
FIG. 4B , theouter tube 106 may be extended partially or completely over the firstflexible polymer arm 112 and the secondflexible polymer arm 114, or over thearms surgical instrument 100 to form a “closed” position. The stiffness of the firstflexible polymer arm 112 and the secondflexible polymer arm 114 may be increased by extending theouter tube 106 and reducing the portions of the firstflexible polymer arm 112 and the secondflexible polymer arm 114 that are positioned outwardly from theouter tube 106. Likewise, where more flexibility is desired, theouter tube 106 may be withdrawn to the point where more, potentially the entirety, of the firstflexible polymer arm 112 and the secondflexible polymer arm 114 are exposed. In a like manner, the amount of thearms outer tube 106 may be controlled in order to control stiffness of the combinedflexible polymer arms arms - As noted above, in preparation for insertion of the
outer tube 106 through a trocar cannula positioned in an incision in the eye, theouter tube 106 may be extended until either (a) the firstflexible polymer arm 112 and the secondflexible polymer arm 114 are located completely within theouter tube 106, or (b) the parts the firstflexible polymer arm 112 and the secondflexible polymer arm 114 extending outwardly form theouter tube 106 are small enough to fit through the cannula (e.g., equal to or smaller than the outer diameter of the outer tube 106). - In the embodiment shown, the forceps (
flexible polymer arms end surfaces flexible polymer arms flexible polymer arms flexible polymer arms - Referring to
FIG. 5A , during use, lower surfaces of the end surfaces 112 d, 114 d are pressed downward against the membrane 500 (e.g., ILM or ERM) positioned over theretina 502. Referring toFIG. 5B , aflap 504 may be raised by drawing the end surfaces 112 d, 114 d towards each other across themembrane 500 in order to grasp theflap 504 firmly. Referring toFIG. 5C , the surgeon may then lift thesurgical instrument 100 away from theretina 502 in order to tear themembrane 500. Referring toFIG. 6 , the surgeon may move the graspingstructure 104 in a circular motion to peel a portion of themembrane 500 away from theretina 502. - The foregoing description is provided to enable any person skilled in the art to practice the various embodiments described herein. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments. Thus, the claims are not intended to be limited to the embodiments shown herein, but are to be accorded the full scope consistent with the language of the claims.
Claims (15)
1. An ophthalmic surgical instrument for peeling a retinal membrane, comprising:
a handle;
an actuator mounted on the handle;
an outer tube having a proximal end mounted to the handle and defining a longitudinal direction;
an inner rod extending within the outer tube; and
a grasping structure secured to a distal end of the inner rod, the grasping structure comprising:
a first polymer arm and a second polymer arm secured to the inner rod and biased outwardly from one another along a transverse direction perpendicular to the longitudinal direction, each of the first polymer arm and the second polymer arm having a distal end that is at an angle between 0 and 90 degrees relative to a vertical direction that is perpendicular to the longitudinal direction and the transverse direction,
wherein the actuator is configured to control relative position of the inner rod and the outer tube in order to extend the grasping structure out of the outer tube and withdraw the grasping structure within the outer tube.
2. The ophthalmic surgical instrument of claim 1 , wherein the inner rod is formed of a first material, and the first and second polymer arms are formed of a second material that is different from the first material.
3. The ophthalmic surgical instrument of claim 2 , wherein the second material is formed over the first material.
4. The ophthalmic surgical instrument of claim 2 , wherein the first material is steel or nitinol.
5. The ophthalmic surgical instrument of claim 2 , wherein the second material is a thermoplastic elastomer.
6. The ophthalmic surgical instrument of claim 5 , wherein the thermoplastic elastomer has a hardness between Shore A 10 and 90.
7. The ophthalmic surgical instrument of claim 2 , further comprising a first arm formed on the inner rod and a second arm formed on the inner rod, the first arm and the second arm comprising the first material, the first polymer arm being secured to the first arm and the second polymer arm being secured to the second arm.
8. The ophthalmic surgical instrument of claim 7 , wherein:
the first arm has a first extension formed thereon, the first polymer arm being molded over the first extension; and
the second arm has a second extension formed therein, the second polymer arm being molded over the second extension.
9. The ophthalmic surgical instrument of claim 1 , wherein the first polymer arm and the second polymer arm are configured to elastically deform sufficiently to fit within the outer tube.
10. The ophthalmic surgical instrument of claim 1 , at least one of the first polymer arm and the second polymer arm are textured to improve gripping of a membrane on a retina of a patient's eye.
11. The ophthalmic surgical instrument of claim 1 , wherein the inner rod is fixed relative to the handle and the outer tube is fixed relative to the actuator.
12. A method for peeling a membrane from a retina of a patient's eye, the method comprising:
inserting a distal end of an outer tube through a cannula in the patient's eye;
extending a grasping structure from the outer tube along a longitudinal direction, the grasping structure secured to an inner rod and having a first polymer arm and a second polymer arm secured to the inner rod and biased outwardly from one another along a transverse direction perpendicular to the longitudinal direction, each of the first polymer arm and the second polymer arm having a distal end that is at an angle between 0 and 90 degrees relative to a vertical direction that is perpendicular to the longitudinal direction and the transverse direction;
pressing the distal end of the first polymer arm and the distal end of the second polymer arm against the membrane; and
withdrawing the grasping structure at least partially into the outer tube thereby urging the first polymer arm and the second polymer arm together in order to form a flap of the membrane and grasp the flap between the first polymer arm and the second polymer arm.
13. The method of claim 12 , further comprising pulling on the flap effective to peel a portion of the membrane from the retina.
14. The method of claim 12 , wherein the outer tube is mounted to a handle having an actuator mounted thereto and coupled to the outer tube, the method comprising moving the actuator to extend the grasping structure from the outer tube and retract the grasping structure within the outer tube.
15. The method of claim 12 , wherein the inner rod comprises nitinol and the first and second polymer arms comprise a thermoplastic elastomer.
Priority Applications (1)
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US18/530,564 US20240197525A1 (en) | 2022-12-14 | 2023-12-06 | Grasping structure for membrane removal |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US202263387331P | 2022-12-14 | 2022-12-14 | |
US18/530,564 US20240197525A1 (en) | 2022-12-14 | 2023-12-06 | Grasping structure for membrane removal |
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US20240197525A1 true US20240197525A1 (en) | 2024-06-20 |
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ID=89222682
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Application Number | Title | Priority Date | Filing Date |
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US18/530,564 Pending US20240197525A1 (en) | 2022-12-14 | 2023-12-06 | Grasping structure for membrane removal |
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US (1) | US20240197525A1 (en) |
WO (1) | WO2024127174A1 (en) |
Family Cites Families (6)
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CN1180506C (en) | 1999-03-26 | 2004-12-15 | 松下电器产业株式会社 | Laminate sheath type battery |
US9089355B2 (en) * | 2003-09-16 | 2015-07-28 | Vitalitec International, Inc. | Surgical clamp inserts with hooked traction elements |
US10973682B2 (en) * | 2014-02-24 | 2021-04-13 | Alcon Inc. | Surgical instrument with adhesion optimized edge condition |
US20160296246A1 (en) * | 2015-04-13 | 2016-10-13 | Novartis Ag | Forceps with metal and polymeric arms |
CA3062114A1 (en) * | 2017-06-28 | 2019-01-03 | Alcon Inc. | Coated forceps for improved grasping |
JP2023545531A (en) * | 2020-10-15 | 2023-10-30 | アルコン インコーポレイティド | Vacuum-assisted forceps for ophthalmological procedures |
-
2023
- 2023-12-06 WO PCT/IB2023/062327 patent/WO2024127174A1/en unknown
- 2023-12-06 US US18/530,564 patent/US20240197525A1/en active Pending
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